Depressive Disorder
Conditions
Interventions
Experimental group:Intravenous drip of esketamine
Control group:Intravenous drip of midazolam
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Outpatients/inpatient aged 18 to 60 years; 2.Meeting the diagnostic criteria of depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) (concise International Neuropsychiatric Interview 7.0 (M.I.N.I 7.0)); 3.After the recent depressive episode was stabilized by a single type of antidepressant, although the type and dosage of the drugs remain unchanged, the condition fluctuates. Defined as follows: (1)After the recent depressive episode was stabilized by a single type of antidepressant, the prescription has not been adjusted; And the number of days during which drug treatment was interrupted =14 at the time of enrollment; (2)The recent depressive episode was stabilized by a single type of antidepressant: the self-reported VAS-1 score of the patient >=8; Although the type and dosage of the drugs remain unchanged, the condition fluctuates: the self-reported VAS-2 score of the patient <=5; 4.The dosage of the antidepressant conforms to Antidepressant Treatment History Form (ATHF-SF) for the determination of the lowest therapeutic dose of the corresponding antidepressant or the lowest therapeutic dose in the corresponding drug label (drugs of other manufacturers not included in ATHF-SF); 5.Able to understand and cooperate with research procedures; 6.Voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1.A history of treatment-resistant depression, schizophrenia, bipolar disorder, and obsessive-compulsive disorder; 2.Patients with mental disorders accompanied by other diseases; 3.Current depressive disorder patients with psychotic symptoms; 4.A history of severe drug allergy or hypersensitivity reactions; 5.Women who are pregnant or breast-feeding; 6.Answer "Yes" to the 4th or 5th item of C-SSRS "suicidal ideation" during the recent depressive episode during screening; Or have committed suicide within the recent depressive episode under the C-SSRS "suicidal behavior"; Or, in the investigator's judgment, a serious risk of suicide; 7.A history of respiratory diseases, such as chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, etc.; 8.A history of cardiovascular disease, such as hypertension, various types of angina, myocardial infarction, etc.; 9.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeds the upper limit of normal (ULN), or total bilirubin exceeds ULN; all abnormal results have clinical significance and were considered unsafe for participating this trial; 10.Free triiodothyronine (FT3) or free thyroxine (FT4) or thyroid-stimulating hormone (TSH) test results are abnormal and have clinical significance; 11.A serious risk of increased blood pressure or intracranial pressure, systolic/diastolic blood pressure exceeding 180/100mmHg, pre-eclampsia and eclampsia, hyperthyroidism, ischemic heart disease and other contraindications to esketamine; 12.Contraindications to midazolam such as hypersensitivity to midazolam or any of its excipients, acute angle-closure glaucoma, and untreated open-angle glaucoma; 13.Received electroconvulsive therapy in the past three months; 14.Have been exposed to ketamine or esketamine and its isomers; 15.A history of drug abuse; 16.The examination results during the screening period are abnormal and have clinical significance; 17.Novel coronavirus nucleic acid test positive; 18.Other conditions considered unsuitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate;Scale score minus from baseline;Duration of effective treatment; | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed